Publications by authors named "Prasanna Kumar Nidamarthy"
Article Synopsis
- Complement 3 glomerulopathy (C3G) is a rare kidney disease caused by issues with the immune system, and iptacopan is being tested as a potential treatment in a study examining its effectiveness and safety.
- In a phase 2 clinical trial with 27 patients, those with native C3G saw a 45% reduction in protein in their urine, while kidney transplant recipients had a significant decrease in C3 deposits in their biopsies after 84 days of treatment.
- Overall, iptacopan showed promising results in improving kidney function and safety, as it normalized certain complement levels and had manageable side effects, with no reported deaths during the study.
Article Synopsis
- Targeting the alternative complement pathway could be a promising treatment approach for immunoglobulin A nephropathy (IgAN), with iptacopan being a new oral drug that inhibits this pathway by specifically targeting Factor B.
- A Phase 2 study tested different doses of iptacopan on IgAN patients and found a significant reduction in urine protein levels after three months, particularly with the 200 mg twice daily dosage.
- Iptacopan was also safe and well-tolerated, showing no serious side effects, which supports its further investigation in an ongoing Phase 3 trial.
Article Synopsis
- Iptacopan (LNP023) is being tested as a new oral treatment for paroxysmal nocturnal hemoglobinuria (PNH) by inhibiting complement factor B and is currently in a phase 2 clinical study.
- In the study, PNH patients were given different doses of iptacopan, and results showed significant reductions in serum lactate dehydrogenase (LDH) levels, with most patients seeing a drop of over 60% by week 12.
- The drug was well tolerated, leading to notable improvements in hemoglobin levels and reductions in other hemolysis markers, with no severe adverse events reported during the trial.
Pharmacokinetic Interaction Between the MEK1/MEK2 Inhibitor Trametinib and Oral Contraceptives Containing Norethindrone and Ethinyl Estradiol in Female Patients With Solid Tumors.
Clin Pharmacol Drug Dev
May 2022
This phase 1 postapproval study assessed the effect of the mitogen-activated protein kinase kinase enzyme 1/enzyme 2 inhibitor trametinib (2 mg once daily, repeat dosing) on the pharmacokinetics of combined oral contraceptives (COCs) containing norethindrone (NE; 1 mg daily) and ethinyl estradiol (EE; 0.035 mg daily) in 19 female patients with solid tumors. Compared with NE/EE administered without trametinib, NE/EE administered with steady-state trametinib was associated with a clinically nonrelevant 20% increase in NE exposure (area under the curve [AUC]) and no effect on EE exposure (geometric mean ratio [geo-mean] of NE/EE + trametinib to NE/EE [90%CI]: NE AUC calculated to the end of a dosing interval at steady-state [AUC ] 1.
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- Tropifexor is a medication that targets the farnesoid X receptor and shows consistent absorption rates without major re-circulation in the body.
- An open-label study found that its pharmacokinetics and safety remain comparable between individuals with hepatic impairment and those with normal liver function after a 200 µg dose.
- The drug is highly protein-bound and displays a slight increase in unbound exposure in patients with moderate to severe liver impairment, suggesting it can potentially be used in severe liver disease without needing dosage adjustments.
Purpose: In the Phase II GEOMETRY mono-1 study, the potent and selective mesenchymal-epithelial transition (MET) inhibitor capmatinib exhibited considerable efficacy in MET exon 14 skipping (METex14)-mutated metastatic non-small cell lung cancer at a dose of 400 mg BID. The current recommended dose is 400 mg BID in tablet formulation, with or without food. This article reports the pharmacokinetic (PK) profile, safety, and tolerability of capmatinib 300 and 400 mg BID given with food in MET-dysregulated advanced solid tumors.
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